Sonnet 2 (EAS) Audio Processor and Maestro 8.0 Software
FDA premarket approval P000025/S112 · decided 2019-08-22
Approval details
- PMA number
- P000025
- Supplement
- S112
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Sonnet 2 (EAS) Audio Processor and Maestro 8.0 Software
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2019-05-24
- Decision date
- 2019-08-22
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval for the SONNET 2 and SONNET 2 EAS audio processors. The SONNET 2 and SONNET 2 EAS audio processors are updates to existing products (SONNET and SONNET EAS).
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